Verification Manager

BioTalent Ltd; Irvine (CA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

BioTalent Ltd in Irvine, CA is seeking a Verification Manager to lead the build-out of a new medical device verification lab. You will establish testing capacity, recruit and mentor staff, and collaborate with an international R&D team to reach MDR/CAPA milestones.

The role requires hands-on lab leadership, IQ/OQ/PQ programs, TMV development, and strong project management in an FDA-regulated environment; travel internationally is expected.

Qualifications

• 5-10+ years in medical device testing or verification in FDA-regulated environment.
• Bachelor's degree in Biomedical, Mechanical, Electrical Engineering or related.
• Experience building a testing lab and calibration program development.
• Hands-on testing of catheters or interventional devices preferred.

Responsibilities

• Lead build-out of the verification lab, including layout and equipment procurement.
• Own IQ/OQ/PQ of test equipment and calibration program setup.
• Develop SOPs, test protocols, and audit-ready lab operations.
• Travel periodically to collaborate with international R&D teams.
• Hire, onboard, and develop the testing team as the site scales.
• Manage lab resources and cross-site coordination.

Skills

Lab build-out leadership

IQ/OQ/PQ proficiency

TMV development

Regulatory compliance

Team leadership

Data analysis

Education

Bachelor's degree in Biomedical, Mechanical, Electrical Engineering or related

Tools

Keyence vision systems

Calibration equipment

Job description

Verification Manager — Medical Device
Location: Irvine, CA (hybrid, 3 days onsite) with some international travel

Position Overview
We're hiring a Verification Manager to lead the build-out of a new product verification lab in Irvine, supporting interventional cardiology testing capabilities. This role will build lab infrastructure, testing capacity, and a team from the ground up, while collaborating closely with an established core lab in Germany. Strong fit for someone who wants to build rather than inherit.

Responsibilities

• Lead build-out of the verification lab: layout planning, equipment selection/procurement, site readiness
• Own IQ/OQ/PQ of test equipment and processes, calibration program setup, and Test Method Validation (TMV)
• Develop SOPs, test protocols, and work instructions for audit-ready lab operations
• Support R&D by providing evaluation tools, test fixtures, and testing capabilities
• Travel periodically to collaborate with the international R&D team during key verification milestones
• Build and lead field return investigation processes for the U.S., partnering with Quality and Regulatory Affairs on MDR, CAPA, and vigilance documentation
• Hire, onboard, and develop the testing team as the site scales
• Manage lab resources, workload prioritization, and cross-functional coordination across sites

Requirements

• 5-10+ years of experience in medical device testing or verification in an FDA-regulated environment
• Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or related discipline
• Demonstrated experience building a testing lab, including TMV, IQ/OQ/PQ, and calibration program development
• Hands-on experience testing catheters or similar interventional/disposable devices, including contaminated returned product
• Experience with complex system testing involving both capital equipment and disposable components
• Experience managing or leading a small technical team
• Cardiovascular device experience preferred but not required

Preferred technical skills:

• Dimensional inspection/measurement systems (e.g., Keyence vision systems)
• Tensile and mechanical testing equipment
• Functional and electrical test setups for complex device assemblies
• Fluid flow, pressure, and leak testing for catheter-based/cardiovascular devices
• Programming for data analysis/tool automation
• Basic statistics knowledge